tbuckley/cabot-search huggingface dataset:
Dual language interview guide to improve understanding of risk perception among newly diagnosed breast cancer patients who are limited English proficient (LEP).
Authors: Melody Karen Schiaffino
Journal: Journal of Clinical Oncology (2023)

e24031 Background: In the U.S. 60% of those diagnosed with cancer are over age 65. This group is also larger, living longer, and more diverse than previous generations. This diversity includes increased proportions of older adults who are limited English proficient (LEP) which is defined as speaking English less than “very well” as measure by the U.S. Census. Access to language services is a protected right both via Title VI of the Civil Rights Act of 1964, the 2000 Executive Order 19166 mandating language services and the 2010 Patient Protection and Affordable Care Act. However, research remains limited in addressing linguistic and cognitive barriers experienced by LEP patients. Methods: Using an adapted forward-translation method from the World Health Organization the goal is for conceptual equivalence not direct translation. This approach includes multiple independent forward translations, a bilingual adjudicator with content expertise and community and expert reviewers. This approach allows for codification of divergence of semantic, conceptual, and normative equivalence. Semantic relates to words and equivalence or eloquence, conceptual refers to the general idea and normative relates to the social-cultural relevance or appropriateness of the topic itself (Pan, de la Puente, 2005). Two trained interpreters conducted forward translations, a third adjudicated. The interview guide was reviewed by two radiation oncologists and tested with a bilingual breast cancer survivor. Results: Semantic and conceptual equivalence were confirmed with expert panel review and are the equivalent of previously used “back-translation” however, we were also able to ensure normative equivalence, or the socio-cultural relevance to our study participants which were LEP Latina breast cancer patients. A final semi-structured interview guide was finalized and approved by the UCSD IRB to be fielded in March 2023. Conclusions: Adapting existing validated instruments requires more than just consideration of terminology, an understanding of semantic, conceptual, and normative equivalence is critical for improving culturally and linguistically appropriate research among minoritized and LEP geriatric oncology populations.
Assessing disparities in lung cancer screening eligibility among high-risk individuals.
Authors: Abdi Gudina, Charles Stewart Kamen, Nikesha Gilmore, Lee Kehoe, Ana Paula Cupertino
Journal: Journal of Clinical Oncology (2023)

10563 Background: Low-dose computerized tomography (LDCT) scanning confers a 20% reduction in lung cancer mortality by diagnosing the disease at earlier, more treatable stages. Racial/ethnic minorities have historically been less likely to be eligible for lung cancer screening. In 2021, the U.S. Preventive Services Task Force (USPSTF) updated its 2013 guideline for lung cancer screening eligibility by reducing the minimum age (55 to 50) and decreasing the cumulative number of cigarette pack-years smoked (30 to 20). The purpose of this study was to assess if the updated guideline will mitigate disparities in lung cancer screening eligibility among high-risk individuals. Methods: Data were obtained from the Behavioral Risk Factor Surveillance System (2017-2019), a population-based survey administered annually by the Centers for Disease Control and Prevention. Only subjects with complete information on the variables used to determine eligibility (age, smoking status, age at first start smoking, age at last smoked, average number of cigarettes smoked each day) (n = 793,537) were included in the final analysis. Logistic regression was used to model the association between predictors and 2021 vs. 2013 lung cancer screening eligibility. Results: Based on the 2013 guideline, Non-Hispanic Blacks (OR: 0.34; 95%CI: 0.31 - 0.38), Hispanics (OR: 0.12; 95%CI: 0.10 – 0.14), and other racial/ethnic minorities (OR: 0.59; 95%CI: 0.54 – 0.64) were less likely to be eligible for lung cancer screening than Non-Hispanic Whites. Using the 2021 guideline, Non-Hispanic Blacks (OR: 0.45; 95%CI: 0.42 - 0.49), Hispanics (OR: 0.15; 95%CI: 0.13 – 0.16), and other racial/ethnic minorities (OR: 0.63; 95%CI: 0.58 – 0.67) remain less likely to be eligible for lung cancer screening than Non-Hispanic Whites. Conclusions: The 2021 guideline slightly reduces racial/ethnic disparities in lung cancer screening eligibility. Further efforts should be made to develop a guideline that better addresses disparities in lung cancer screening eligibility to reduce lung cancer deaths in racial minorities.
A randomized, open-label, phase 2 study evaluating abemaciclib in combination with irinotecan and temozolomide in participants with relapsed or refractory Ewing sarcoma.
Authors: Gertjan VAN HAL, Alba Rubio-San-Simón, Chitose Ogawa, Antonio Juan-Ribelles, Holly Knoderer, Jeremy Howard Lewin
Journal: Journal of Clinical Oncology (2023)

TPS11580 Background: Ewing’s sarcoma (ES) is the second most common malignant bone tumor affecting children and young adults. Patients with relapsed disease have a poor prognosis and need effective therapies. EWS-FLI1, the most common ES fusion gene (90-95% of cases), is an oncogenic transcription factor that downregulates intrinsic cyclin-dependent kinase (CDK) inhibitors, CDKN1A and CDKN1C, which promote cell cycle arrest and upregulates CDK4, which drives entry into the cell cycle. This provides a biological rationale for the clinical evaluation of CDK4/6 inhibitors in ES. Abemaciclib is a selective CDK4/6 inhibitor approved for the treatment of breast cancer. It is approximately 14 times more potent against CDK4/cyclin D1 than CDK6/cyclin D3 in enzymatic assays and has the advantage of continuous dosing schedule without breaks for neutrophil recovery. Abemaciclib is currently also in clinical development for paediatric patients with relapse/refractory solid tumors in combination with irinotecan and temozolomide (JPCS study, NCT04238819). This study, NCT05440786, will evaluate the potential benefit of adding abemaciclib to irinotecan plus temozolomide for the treatment of relapsed/refractory ES. Methods: This randomized, open-label, Phase 2 study is part of the CAMPFIRE master protocol. It is enrolling paediatric and young adult patients (1–39 years) with relapsed/refractory ES or ES-like tumors. Approximately 45 patients will be randomized 2:1 between 2 arms: irinotecan and temozolomide with or without abemaciclib. Stratification factors include age, pulmonary/non-pulmonary site of metastases, and time to recurrence from initial diagnosis. Patients will receive irinotecan (50 mg/m 2 /day intravenously) and temozolomide (100 mg/m 2 /day orally) on days 1-5. Abemaciclib will be administered orally twice-daily on a continuous 21-day cycle. The abemaciclib dose will be 55mg/m 2 BID for patients &lt; 18 years and 100mg BID for those ≥18 years. Besides 25 and 50mg tablets, abemaciclib will be available as 2.5mg granules allowing administration of doses as low as 10mg to patients with a body surface area lower than 0.2m 2 . Treatment continues until disease progression or other discontinuation criteria are met. The primary endpoint is progression-free survival (PFS) determined by a blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1. Key secondary endpoints include overall survival, objective response rate, duration of response, disease control rate, PFS determined by investigator assessment, safety, and pharmacokinetics. Additional analysis includes exploratory biomarker testing. This study is open and actively enrolling in Australia, Europe, Japan, and United States. Clinical trial information: NCT05440786 .
Socioeconomic and demographic factors on academic center accessibility in sebaceous adenocarcinoma: An NCDB analysis.
Authors: Xinxin Wu, Michelle Swedek, Peter T. Silberstein, Victoria Vardell
Journal: Journal of Clinical Oncology (2023)

e21501 Background: Sebaceous adenocarcinoma (SA) is a rare, aggressive adnexal tumor shown to have both local and distant metastatic potential. The 5-year overall survival rate for this cancer is 78% for localized/regional disease and 50% for metastatic disease. Improved survival in other skin malignancies, such as melanoma, has been previously linked to treatment at academic cancer centers. The National Cancer Database (NCDB) was analyzed to determine variables impacting treatment at academic versus non-academic facility types in SA. Methods: A retrospective cohort analysis using the NCDB from 2004 to 2019 included patients diagnosed with histologically confirmed SA (N = 3,378). Socio-demographic factors (sex, age, race, Hispanic status, insurance type, urban/rural designation, facility location, education, income, distance from facility, and Charlson-Deyo score) were analyzed using Pearson Chi-squared tests and multivariate analysis of factors on academic center accessibility (facility type) was performed via binary logistic regression. A significance level of 0.05 was used. Results: The number of cases diagnosed with SA has steadily increased from 2004 to 2019 (152 and 287, respectively, R2 = 0.894). Most patients were male (59.1%), White (89.8%), not Hispanic (89.6%), insured (95.7%), and lived in an urban area (98.4%). There was a statistically significant difference between sex, race, insurance type, urban/rural designation, facility location, education, income, and distance from residence to the facility on academic facility type. Male patients were 1.3 times more likely to access academic centers compared to female patients (p &lt; 0.001, CI = [0.681 - 0.911]). Patients with median household incomes in the top quartile were also 2.2 times more likely than those in the bottom quartile to receive treatment at an academic center (p &lt; 0.001, CI = [1.676 - 2.992]). Conclusions: There has been an upward trend in the diagnosis of SA since 2004 with a predilection for White males. Female patients and patients with a lower income are less likely to receive treatment at an academic center. Given the rarity of the disease, this study serves as a valuable tool for understanding the factors associated with facility-type access. Future studies aim to determine the effect of academic center type on overall survival. Additional research is needed to understand the difference in treatment at academic versus non-academic facilities.
Pre-diagnosis dietary patterns and risk of multiple myeloma in the NIH-AARP cohort.
Authors: Richa Parikh, Francesca Castro, Jelyn C. Eustaquio, Andriy Derkach, Janine Joseph, Alexander M. Lesokhin, Saad Zafar Usmani, Urvi A Shah
Journal: Journal of Clinical Oncology (2023)

10635 Background: Despite patient interest in knowing whether diet is linked to multiple myeloma (MM), there is limited research on dietary patterns and MM risk (Malik et al. BCJ 2022). Two studies have assessed this risk, albeit with a small number of MM cases. The EPIC-Oxford cohort and Oxford Vegetarian study (65 MM cases) showed that fish eaters, vegetarians and vegans had significantly reduced MM risk compared to meat eaters (Key et al. AJCN 2014). The Nurses’ Health Study and Health Professionals Follow-up Study (478 MM cases) showed a significantly increased MM risk in men with Empirical Dietary Inflammatory Pattern (Lee et al. JNCI Can Spectr 2019). To our knowledge, this is the largest epidemiologic study to date assessing pre-diagnosis dietary patterns and MM risk. Methods: The NIH-AARP Diet and Health study is a prospective cohort of 567,169 persons who completed a food frequency questionnaire in 1995-1996 and were followed until December 2011. Healthy Eating Index-2015 (HEI-2015), Healthy Diet Score (HDS), alternate Mediterranean Diet (aMED) and healthful Plant-based Diet Index (hPDI) scores were calculated using a priori defined methods and grouped into quartiles, with higher scores reflecting healthier eating patterns. We prospectively evaluated the association between pre-diagnosis dietary patterns and MM incidence in this cohort. Hazard ratios (HR) and 95% confidence intervals (95%CI) were estimated using multivariate Cox proportional hazards models adjusted for age at study entry, sex, race, body mass index, education, and total energy intake (by residual method). Sensitivity analysis was conducted to assess reverse causality by excluding MM cases diagnosed within one year of follow-up. Results: Among 392,589 participants (after exclusions), a total of 1,366 MM cases (59% males; 92% non-Hispanic whites) were identified during the follow-up period. Analysis revealed a significant association between hPDI scores and reduced MM risk (highest vs lowest quartile, HR 0.85; 95%CI 0.73-1.0; p=0.043) (Table). In sensitivity analysis (1,302 MM cases), the association was no longer significant (HR 0.87; 95%CI 0.74-1.03; p 0.09) but trended in the same direction. This may be due to small sample size, given MM is a rare disease. HEI-2015, HDS and aMED scores were not associated with MM risk. Conclusions: A healthful plant-based diet was associated with reduced MM risk in the NIH-AARP cohort. These results will help oncologists and patients make informed choices about their diet. [Table: see text]
Obesity and triple negative breast cancer diagnosis among premenopausal women.
Authors: Caitlin Taylor, Melanie Anne Sheen, Rabia Cattie, Victoria Chung, Marcia Henry, Susan Olet, Matthew Alberti, Helen Yuan, James Peeples, Raina Saxena
Journal: Journal of Clinical Oncology (2023)

e22513 Background: Obesity is a known risk factor for the development of postmenopausal breast cancer, specifically hormone-receptor positive breast cancer, and is associated with poor outcomes and decreased overall survival. While obesity in pre-menopausal patients is thought to be protective against the development of breast cancer, application across breast cancer subtypes remains less clear. Methods: We performed a retrospective analysis of 758 patients under 40 years of age diagnosed with breast cancer at our institution over 10 years. Variables including age at diagnosis, breast cancer subtype, race and BMI were evaluated. To assess the association between body mass index (BMI), race and triple negative breast cancer (TNBC), odds ratios (OR) and their associated 95% Confidence interval (CI) OR are reported. Results: Obese patients (BMI &gt;30) were more likely to have TNBC compared with non-obese patients [OR=1.46, 95% CI [1.07 – 2.00), P=0.0161]. Black patients had a twofold likelihood of having TNBC compared with white patients regardless of BMI [OR=2.16, 95% CI [1.56 – 2.97), P&lt;0.0001]. Conclusions: Obese patients under 40 years of age were more likely to be diagnosed with TNBC than non-obese patients. Our data highlights ongoing disparities among TNBC diagnosis and emphasizes the importance of weight loss interventions targeted towards premenopausal women at high risk for breast cancer. [Table: see text]
Adjuvant polypeptide vaccines for high-risk uveal melanoma.
Authors: Elizabeth Mary Gaughan, Nicholas Lucchesi, Ruyun Jin, Craig L. Slingluff
Journal: Journal of Clinical Oncology (2023)

e21509 Background: Due to biologic differences, uveal melanoma patients are often excluded from clinical trials for cutaneous melanoma; however, many antigens are shared between the two melanoma subtypes. Thus, our vaccine trials at the University of Virginia (UVA) have allowed enrollment of high-risk uveal melanoma patients, who have substantial risk of relapse without FDA-approved adjuvant therapy available. For the present study, we hypothesized that the vaccines would be well-tolerated and immunogenic in this population. We examined the clinical, immunogenicity and safety outcomes of subjects with uveal melanoma enrolled in our adjuvant vaccine clinical studies. Methods: Patients were identified through participation in an adjuvant vaccine study at UVA between 2012-2022. Ten patients received the 6-Melanoma-Helper Peptide (6-MHP) vaccine through Mel-65 and Mel-66 clinical trials (NCT03617328 and NCT04364230) and one patient received the 12-peptide MELITAC vaccine through the Mel-58 clinical trial (NCT01585350). Clinical outcomes included relapse-free (RFS) and overall survival (OS) and trial toxicity reporting. Immunogenicity was assessed by ex vivo interferon-gamma ELISpot assay of peripheral T cells. OS and RFS were reported by Kaplan-Meier survival analysis and compared by log rank test between groups. Results: Of the 11 identified patients, nine were male (82%) and two were female (18%), with a median age of 64 years. All patients were high risk by molecular testing, the majority by Castle Bioscience DecisionDx-UM. Five were PRAME positive, five PRAME negative, and one not reported. In the cohort, three patients had uveal melanoma recurrence and one subject died from metastatic disease during the evaluation period. The 5-year RFS and OS were 71% (95% CI 43-100) and 80% (95% CI 52-100), respectively. Two patients experienced dose-limiting, grade 3 toxicities to the vaccine, requiring early trial discontinuation, including one grade 3 injection-site reaction and one grade 3 uveitis. Nine patients experienced grade 1-2 toxicities, mostly injection-site reactions and constitutional symptoms. Of nine patients with available immunogenicity data, five (55%) had direct antigen-mediated immune response to vaccine. Two patients’ responses are pending. Patients with immunogenic response had a non-significant trend toward better RFS and OS (both p = 0.22). The 3-year RFS and OS were 100% for subjects with T cell response and the RFS and OS were 50% (95% CI 13-100) for patients without T cell response. Two of the relapsed patients did not have an immune response to vaccine, and response data were not available for the third. Conclusions: Melanoma polypeptide vaccines are immunogenic and safe in patients with uveal melanoma. Our early data suggests the possibility of early benefit with direct antigen response, though longer follow up and further study will be needed to investigate these findings.
Polygenic risk scores in assessing lung cancer susceptibility in non-Hispanic White and Black populations.
Authors: Matthew R Trendowski, Chrissy Lusk, Angie Wenzlaff, Christine Neslund-Dudas, Shirish M. Gadgeel, Ayman Soubani, Ann G. Schwartz
Journal: Journal of Clinical Oncology (2023)

10548 Background: Polygenic risk scores (PRS) have become an increasingly popular approach to evaluate cancer susceptibility, but have not adequately represented Black patients in model development. We used previously identified single nucleotide polymorphisms (SNPs) and annotated SNPs in associated gene regions to develop PRS in non-Hispanic Whites and Blacks using the INHALE dataset. Methods: Using the Multi-Ethnic Genotype Array, 1,204 SNPs for non-Hispanic Whites and 1,515 SNPs for Blacks were evaluated for their association with lung cancer risk adjusting for age, sex, total pack-years, family history of lung cancer, history of COPD and the top five PCs for genetic ancestry. Gene region-specific significant SNPs (p &lt; 0.05) were used to develop race-specific PRS. Results: The race-specific PRS included different sets of significant SNPs and were highly associated with lung cancer risk in both non-Hispanic Whites (OR = 1.07, 95% CI: 1.05-1.09, p = 3.44x10 -9 ) and Blacks (OR = 1.12, 95% CI: 1.08-1.17, p = 9.14x10 -8 ). These models remained significant for both Whites (OR = 1.05, 95% CI: 1.03-1.09, p = 0.0004) and Blacks (OR = 1.08, 95% CI: 1.01-1.15, p = 0.01) who currently do not meet USPSTF screening guidelines. AUC analysis demonstrated the Black-specific model (AUC = 0.68) outperformed the White-specific model (AUC = 0.57) (p = 0.03) when examined exclusively in the Black cohort. Conclusions: Using previously validated SNPs and gene regions, we developed race-specific PRS in non-Hispanic White and Black INHALE participants. Further validation of PRS could enable the incorporation of genetic risk modeling into lung cancer screening to identify patients who do not have traditional risk factors for lung cancer, as well as stratify patients into different levels of risk based on their genetic profile. Through the development of a reliable genetic risk factor prediction model, clinicians will have another method by which to evaluate lung cancer susceptibility, potentially leading to earlier diagnoses that portend more favorable treatment outcomes.
Clinical trial knowledge among cancer survivors in the United States: The role of health information technology.
Authors: Comfort Adewunmi, Joseph Atarere, Onyema Greg Chido-Amajuoyi, Henry Onyeaka, Ange Mele, Nelson Onyeaka, Oluseyi Abidoye, Andrew Thomas Johnson
Journal: Journal of Clinical Oncology (2023)

e24039 Background: Clinical trials are essential in the evaluation of new antineoplastic therapies. However, studies have consistently reported suboptimal levels of clinical trial knowledge among adult cancer patients, and less than 5% of them participate in clinical trials. Health information technology (HIT) has shown promise in health promotion and may prove useful in bridging the knowledge gap in clinical trials among cancer survivors. Methods: We obtained data from 3,865 adults who completed the 2020 Health Information National Trends Survey of which 626 (16.2%) were cancer survivors. Using chi-squared tests, we examined the prevalence of HIT use in the general population and by cancer history. We also examined the impact of HIT use on clinical trial knowledge separately for cancer survivors and those with no cancer history using multivariable logistic regression models. Results: 63.8% of cancer survivors reported having some knowledge of clinical trials. Almost half of them used HIT to communicate with doctors (47.1%) and make health appointments (49.4%), about two-fifths (42.2%) used HIT in checking test results and 68.0% reported using HIT to look up health information online. In the adjusted models, the use of HIT in communicating with doctors [OR 2.79; 95% CI (1.41, 5.54)], checking test results [OR 2.47; 95% CI (1.12, 5.43)] and looking up health information online [OR 2.84; 95% CI (1.04, 7.77)] was associated with increased knowledge of clinical trials. Conclusions: Our findings suggest a positive association between HIT utilization and higher clinical trial knowledge levels. These results are encouraging given the rapid increase in mobile technology access globally and the increased use of HIT since the onset of the COVID-19 pandemic. There is a potential opportunity to leverage digital technology in improving clinical trial participation by increasing knowledge levels.